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Model Number 190-30-08 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.Concomitant device: novation ehxl natural liner g3 36mm; (cn: 140-36-53, sn: (b)(4)).Alteon ha stem collared standard size 8 (cn: 190-30-08, sn: (b)(4)).Biolox delta femoral head 36mm od, +0mm (cn: 170-36-00, sn: (b)(4)).
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Event Description
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As reported, approximately 11 months postop the initial left tha.This (b)(6) y/o male with a history of osteoarthritis, was revised.The patient received a new xle 40mm lipped liner, a 19x245 monobloc and a 40mm +10 head.Devices not returning.The patient requested the implants.Patient was last known to be in stable condition following the event.
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Manufacturer Narrative
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Section h10: (h3) the evaluation of the of the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic loosening of the femoral stem.However, this cannot be confirmed because the component was not returned for evaluation.(d11) concomitant device: novation ehxl natural liner g3 36mm (cn: 140-36-53, sn: (b)(6).Alteon ha stem collared standard size 8 (cn: 190-30-08, sn: (b)(6).Biolox delta femoral head 36mm od, +0mm (cn: 170-36-00, sn: (b)(6).
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Search Alerts/Recalls
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